OTC - ACTIVE INGREDIENT SECTION
Active Ingredient.........Purpose
Hydrocortisone 1% .....Anti-itch
TrueLipids 1% Hydrocortisone Barrier Cream
- Manufacturer
- Claridei Laboratories
- Effective date
- 2025-12-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:23:04
Label at a glance#
ProductTrueLipids 1% Hydrocortisone Barrier Cream
Active ingredientHYDROCORTISONE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Uses
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
- eczema
- psoriasis
- poison ivy, oak, sumac
- insect bites
- detergents
- soaps
- cosmetics
- jewelry
- seborrheic dermatitis
- temporarily relieves external anal and genital itching
- other uses of this product should only be under the advice and supervision of a doctor
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
INDICATIONS & USAGE SECTION
Stop use and ask a doctor if
- condition worsens
- rectal bleeding occurs
- symptoms persist more than 7 days or clear up and occur again within a few days. do not begin use of any other hydrocortisone product unless you have asked a doctor
WARNINGS SECTION
Warnings
For external use only
Do not use
- in the genital area if you have a vaginal discharge. consult a doctor
- for the treatment of diaper rash. consult a doctor
when using this product
avoid contact with eyes
do not use more than directed unless told to do so by a doctor
do not put directly into rectim by using fingers or any mechanical device or applicator
DOSAGE & ADMINISTRATION SECTION
Directions
- for itching of skin irritation, inflammation and rashes:
- adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
- children under 2 years of age: ask a doctor
- for external anal and genital itching adult:
- when practical clean the affected area with mild soap and water and rinse thoroughly
- gently dry by patting or blotting with toilet tissueor a soft cloth before applying
INACTIVE INGREDIENT SECTION
Inactive ingredients
Water, Caprylic/capric Triglyceride, Petrolatum, Neopentyl Glycol Diheptanoate, Glyceryl Stearate, Polyglyceryl-2 Stearate, Isostearyl Isostearate, Cetyl Allcohol, Propanediol (from Corn) , Glycerin, Stearyl Alcohol, Euphorbia Cerifera (Candelilla Wax), C10-30 Cholesterol/Lanosterol Esters, Potassium Stearate, Glycyrrhetinic Acid(from Licorice root), Glyceryl Distearate, Stearic Acid, Caprylyl Glycol, Xanthan Gum, Niacinamide, 1,2-Hexanediol, Phytospingosine, Disodium EDTA, Ceramide NP, Tocopherol
OTHER SAFETY INFORMATION
Other information
store at 20°-25ºC (68º-77ºF)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
CLMD
Sensitive Skin Care
True Lipids
1% Hydrocortisone Barrier Cream
Net Wt 1.7 fl oz (50g)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 4 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 4 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 4 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 4 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 4 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0851714005030 | GTIN-13: 0851714005030 EAN-13: 0851714005030 GTIN-12: 851714005030 UPC-A: 851714005030 GTIN storage (14 digits): 00851714005030 | CLMD-TL-Hydrocortisone-50g-Carton-Path.jpg |
| QR code link | QR Code |  cherylleemd.com/lipids | CLMD-TL-Hydrocortisone-50g-Carton-Path.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61387-252-01 | TrueLipids 1% Hydrocortisone Barrier Cream | 50 g in 1 TUBE | CREAM | 50 | 4 |
Products#
Every source-derived product name is available through these pages.
- TrueLipids 1% Hydrocortisone Barrier Cream
- Hydrocortisone
- MEDIUM-CHAIN TRIGLYCERIDES
- TOCOPHEROL
- POLYGLYCERYL-2 STEARATE
- CANDELILLA WAX
- POTASSIUM STEARATE
- ENOXOLONE
- STEARIC ACID
- GLYCERYL MONOSTEARATE
- C10-30 CHOLESTEROL/LANOSTEROL ESTERS
- CAPRYLYL GLYCOL
- NIACINAMIDE
- PHYTOSPHINGOSINE
- EDETATE DISODIUM ANHYDROUS
- PETROLATUM
- GLYCERIN
- GLYCERYL DISTEARATE
- XANTHAN GUM
- 1,2-HEXANEDIOL
- CERAMIDE NP
- ISOSTEARYL ISOSTEARATE
- WATER
- NEOPENTYL GLYCOL DIHEPTANOATE
- STEARYL ALCOHOL
- CETYL ALCOHOL
- PROPANEDIOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61387-252 | 61387-252-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2025-12-10 | legacy-cache | 2026-10-21 17:51:25 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TrueLipids 1% Hydrocortisone Barrier Cream | HYDROCORTISONE | Claridei Laboratories | 037395dc-5b96-052e-e063-6394a90a26e4 | 2025-12-15 | Warnings | 61387-252-01 61387-252 61387025201 46012e53-986d-7eb7-e063-6294a90a56ac 037395dc-5b96-052e-e063-6394a90a26e4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.